Pramipexole for Binge Eating Disorder

This study has been withdrawn prior to enrollment.
(No participants were recruited and study has been closed.)
Sponsor:
Information provided by (Responsible Party):
Kristine Steffen, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier:
NCT01106053
First received: April 15, 2010
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder.


Condition Intervention Phase
Binge Eating Disorder
Drug: Pramipexole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by Neuropsychiatric Research Institute, Fargo, North Dakota:

Primary Outcome Measures:
  • Frequency of binge eating [ Time Frame: Baseline followed by weekly during the seven week protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: Baseline followed by weekly during the seven week protocol ] [ Designated as safety issue: No ]
  • Frequency and extent of craving for food using validated instruments [ Time Frame: Baseline followed by weekly during the seven week protocol ] [ Designated as safety issue: No ]
  • Assessment of mood ratings using a validated instrument [ Time Frame: Baseline followed by weekly during the seven week protocol ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2010
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pramipexole
Open-label trial of pramipexole.
Drug: Pramipexole
Pramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day).
Other Name: Mirapex

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Age 18-50 years
  • Women of child-bearing potential and males must agree to practice an accepted method of birth control. All women must have a negative pregnancy test at baseline.
  • Good general health as demonstrated by history and physical examination.
  • Body mass index of 30 kg/m2 or higher at the screening visit.
  • Meet criteria for binge eating disorder as assessed through the SCID-1 and EDE.

Exclusion Criteria:

  • Subjects with any unstable medical condition, or any current or past medical condition which in the opinion of the study physician and/or the principal investigator may increase the risks associated with pramipexole and study participation. Medical appropriateness will be determined through history and physical exam.
  • Subjects with any current Axis I psychiatric diagnosis as determined through the Structured Clinical Interview for DSM-IV for Axis I disorders (SCID-1) interview (aside from BED).
  • Subjects with a Hamilton Depression Rating Scale score greater than or equal to 12 at the screening visit.
  • Subjects who report any history of hallucinations or delusions.
  • Participants taking an antidepressant or other regularly used psychotropic medication which may confound the study results
  • Subjects with any current or history of an impulse control spectrum disorder, other than binge eating disorder,(such as pathological gambling, compulsive shopping, etc.) at screening as determined by the Structured Clinical Interview for DSM-IV Impulse Control Module.
  • Subjects with any history of suicide attempts or current suicidal ideations.
  • Subjects that have used tobacco products on a routine basis within the past six months.
  • Subjects enrolled in any formal treatment programs or research protocols for binge eating disorder at present, or within the past 30 days.
  • Subjects routinely taking any medication known to produce weight change (ex. olanzapine, amitriptyline, steroid medications, etc., other than oral contraceptives, stable thyroid replacement drugs, etc.), or medications with drug-drug interactions with pramipexole.
  • Subjects who are currently breast-feeding.
  • Subjects who have participated in an investigational drug trial in the past 30 days.
  • Subjects who meet DSM IV-TR criteria for alcohol or drug abuse in the past year.
  • Subjects with an allergy to pramipexole or tablet constituents.
  • Subjects with hepatic dysfunction as determined through a hepatic panel obtained at the screening visit.
  • Subjects with an elevated blood pressure or pulse at screening (140/90 mmHg or above or pulse of greater than 100 beats/minute after being seated and stationary for at least five minutes, or as determined at the discretion of the study physician and/or principal investigator) or history of serious cardiac events (myocardial infarction, arrhythmia, stroke, etc).
  • Subjects with a history of renal dysfunction or with a creatinine clearance of less than 60 ml/min based upon a serum creatinine obtained during screening and as calculated with the Cockroft and Gault equation.
  • Subjects with a positive urine drug screen.
  • Any participant with Parkinson's disease or symptoms suggestive of probable Parkinson's disease.
  • Subjects who have an Epworth Sleep Scale (ESS) score of >7 at screening. ESS scores > 7 have been associated with an increased risk of sleep attacks (Plowman et al., 2005).
  • Any participant who demonstrates clinically significant orthostatic blood pressure changes or is symptomatic during the screening visit, as defined under "orthostatic blood pressure monitoring."
  • History of bariatric surgery.
  • Participants who report a history of obstructive sleep apnea, excessive fatigue, or any sleep disorder which in the opinion of the principal investigator or study medical personnel would increase the participant's risk of experiencing excessive somnolence with pramipexole.
  • Participant has had a change in medication regimen in the last month (dose, starting a new medication, or stopping a medication).
  • Participant is employed by, or has an immediate family member employed by NRI.
  • Participant has participated in a formal weight loss program in the last month (e.g. Weight Watchers, Jenny Craig, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106053

Sponsors and Collaborators
Neuropsychiatric Research Institute, Fargo, North Dakota
Investigators
Principal Investigator: Kristine J Steffen, PharmD, PhD Neuropsychiatric Research Institute, Fargo, ND
  More Information

Additional Information:
No publications provided

Responsible Party: Kristine Steffen, Reseach Scientist, Neuropsychiatric Research Institute, Fargo, North Dakota
ClinicalTrials.gov Identifier: NCT01106053     History of Changes
Other Study ID Numbers: NEDA-Pramipexole
Study First Received: April 15, 2010
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration
United States: University of North Dakota Institutional Review Board

Keywords provided by Neuropsychiatric Research Institute, Fargo, North Dakota:
Binge eating disorder
Food craving
Obesity
Pramipexole
Mirapex
Binge

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Pramipexol
Dopamine Agonists
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 24, 2014